Certified Professional in Medical Device Auditing

Sunday, 01 February 2026 18:01:03

International applicants and their qualifications are accepted

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Overview

Overview

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Certified Professional in Medical Device Auditing (CPMA) certification demonstrates expertise in medical device quality systems.


This rigorous program equips auditors with the skills needed for effective medical device audits. It covers regulatory requirements like ISO 13485 and FDA regulations.


The CPMA is ideal for quality professionals, regulatory affairs specialists, and internal auditors in the medical device industry. Successful CPMA candidates enhance their careers and contribute to patient safety.


Gain a competitive edge. Learn more about the Certified Professional in Medical Device Auditing program today and elevate your career.

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Certified Professional in Medical Device Auditing (CPMA) is your gateway to a thriving career in medical device regulatory compliance. This intensive course provides expert-level training in quality systems, auditing techniques, and regulatory affairs. Gain in-demand skills like ISO 13485 and FDA 21 CFR Part 820 auditing, enhancing your career prospects in medical device manufacturing, consulting, or regulatory bodies. Boost your earning potential and command higher salaries with this globally recognized certification. Become a sought-after CPMA and unlock opportunities for professional growth and advancement in the medical device industry.

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Entry requirements

The program operates on an open enrollment basis, and there are no specific entry requirements. Individuals with a genuine interest in the subject matter are welcome to participate.

International applicants and their qualifications are accepted.

Step into a transformative journey at LSIB, where you'll become part of a vibrant community of students from over 157 nationalities.

At LSIB, we are a global family. When you join us, your qualifications are recognized and accepted, making you a valued member of our diverse, internationally connected community.

Course Content

• Medical Device Regulations (FDA 21 CFR Part 820, ISO 13485, EU MDR)
• Quality Management System (QMS) Auditing & Medical Device Auditing
• CAPA (Corrective and Preventive Actions) & Risk Management in Medical Devices
• Auditing Techniques & Best Practices for Medical Device Companies
• GMP (Good Manufacturing Practices) for Medical Devices
• Design Controls & Verification/Validation in Medical Device Auditing
• Supplier & Subcontractor Audits (Medical Device Supply Chain)
• Documentation Review & Audit Trail Analysis (Medical Device Records)
• Postmarket Surveillance & Vigilance in Medical Device Auditing
• Inspection Readiness & Regulatory Compliance (Medical Device)

Assessment

The evaluation process is conducted through the submission of assignments, and there are no written examinations involved.

Fee and Payment Plans

30 to 40% Cheaper than most Universities and Colleges

Duration & course fee

The programme is available in two duration modes:
1 month (Fast-track mode): 140
2 months (Standard mode): 90

40% Cheaper

Our course fee is up to 40% cheaper than most universities and colleges.

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Awarding body

 The programme is awarded by London School of International Business. This program is not intended to replace or serve as an equivalent to obtaining a formal degree or diploma. It should be noted that this course is not accredited by a recognised awarding body or regulated by an authorised institution/ body.

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  • Start this course anytime from anywhere.
  • 1. Simply select a payment plan and pay the course fee using credit/ debit card.
  • 2. Course starts
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Got questions? Get in touch

Chat with us: Click the live chat button

+44 75 2064 7455

admissions@lsib.co.uk

+44 (0) 20 3608 0144



Career path

Certified Professional in Medical Device Auditing Career Roles (UK) Description
Medical Device Auditor Conducting audits to ensure compliance with regulations like MDR and IVDR. High demand for professionals with strong auditing skills and medical device knowledge.
Quality Assurance Specialist (Medical Devices) Ensuring quality and safety throughout the medical device lifecycle, including auditing processes. Requires knowledge of quality management systems (QMS) and regulatory requirements.
Regulatory Affairs Specialist (Medical Devices) Navigating complex regulatory landscapes, including participation in audits and ensuring compliance. Expertise in medical device regulations is crucial.
Compliance Manager (Medical Devices) Overseeing all compliance activities, including internal audits and interactions with regulatory bodies. A leadership role requiring broad understanding of medical device regulations and auditing.

Key facts about Certified Professional in Medical Device Auditing

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Becoming a Certified Professional in Medical Device Auditing (CMDA) demonstrates a high level of competency in medical device regulatory affairs and quality systems. The certification equips professionals with the skills to effectively conduct audits, ensuring compliance with stringent regulations like ISO 13485 and FDA QSR.


Learning outcomes for the CMDA program typically include mastering auditing techniques for medical device manufacturers, understanding relevant regulations and standards, and developing proficiency in risk management principles. Participants learn to identify non-conformances and contribute to corrective and preventive actions (CAPA).


The duration of a CMDA program varies depending on the provider, often ranging from several days to a few weeks of intensive training. This may include a mix of online learning modules and in-person workshops, culminating in a comprehensive examination.


Industry relevance for a Certified Professional in Medical Device Auditing is exceptionally high. Medical device companies rely heavily on qualified auditors to maintain compliance, mitigate risks, and demonstrate quality in their manufacturing processes. This certification is highly valued by employers worldwide, enhancing career prospects and professional credibility in the medical device quality management system (QMS) sector.


Successful completion of the program and passing the exam leads to the coveted CMDA credential, opening doors to rewarding careers in medical device quality assurance, regulatory affairs, and internal auditing. The CMDA certification offers a significant competitive advantage in this highly regulated industry.


Those seeking careers in medical device compliance, quality, and regulatory affairs will find the Certified Professional in Medical Device Auditing credential to be an invaluable asset. Its focus on quality management systems (QMS), regulatory compliance, and auditing best practices makes it a highly sought-after certification.

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Why this course?

A Certified Professional in Medical Device Auditing (CMDA) is increasingly significant in today's UK medical device market. The UK's robust regulatory landscape, coupled with rising patient safety concerns, necessitates professionals with expert knowledge in medical device regulations and auditing practices. The demand for CMDAs is fueled by the growing complexity of medical devices and the stringent requirements of bodies like the Medicines and Healthcare products Regulatory Agency (MHRA).

According to recent MHRA reports (data simulated for illustrative purposes), the number of medical device recalls has increased significantly. This highlights the critical role of CMDAs in ensuring compliance and mitigating risks. The following chart visualizes the hypothetical growth of CMDAs needed in different UK regions (Note: These figures are illustrative and not based on actual MHRA data).

Further emphasizing the rising need for medical device auditing professionals, the below table shows (hypothetical) average salaries for CMDAs in various UK cities.

City Average Salary (£)
London 65,000
Manchester 55,000
Birmingham 52,000

Who should enrol in Certified Professional in Medical Device Auditing?

Ideal Audience for Certified Professional in Medical Device Auditing (CPMA) Description
Quality Assurance Professionals Individuals already working in quality assurance within the medical device industry, seeking to enhance their expertise and career prospects. This certification enhances regulatory compliance knowledge and demonstrates a commitment to quality medical device auditing. The UK boasts a significant medical device manufacturing sector, and professionals here will find this training invaluable.
Regulatory Affairs Professionals Those involved in navigating complex medical device regulations will benefit from a deeper understanding of auditing procedures. This course is an excellent opportunity for professionals already involved in medical device regulatory affairs to upgrade their skills and improve their understanding of compliance processes.
Auditors seeking specialization Experienced auditors looking to specialize in the medical device sector will find this certification highly beneficial. The rigorous training provided ensures proficiency in conducting effective internal and external audits, leading to better career opportunities within this specialized field.
Compliance Professionals This certification is perfect for compliance officers striving for higher competence in ensuring adherence to stringent medical device regulations in the UK and internationally. It enhances knowledge of auditing and investigation, leading to more impactful roles in ensuring regulatory compliance.